BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 7525815 · Received May 18, 2018

    Report

    Report Number
    3005180920-2018-00347
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 18, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 MAY 2018; LOT 130678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2013. EXPIRATION DATE: 2018-04-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLED: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 REFERENCE 01.29.202 (K112115); LOT 125618: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2013. EXPIRATION DATE: 2018-01-31; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP ACETABULAR SHELL Ø 52 REFERENCE 01.26.52MB (K083116); LOT 130119: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APRIL 2013 EXPIRATION DATE: 2018-03-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 REFERENCE 01.26.2852MHC (K092265); LOT 130093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MARCH 2013. EXPIRATION DATE: 2018-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 4 YEARS AND 7 MONTHS AFTER PRIMARY. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2018. ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369563 AMISTEM H HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 130678 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention